Implanted medical devices, especially pacemakers, have changed and saved lives, but they've generally been considered single-use machines. Now that concept is changing.
The story behind the realization that pacemakers could be reused came with two nearly simultaneous events in metro Detroit, according to News 6 sister station WDIV.
Ten years ago, George Samson, the president of World Medical Relief in Southfield, came across an article in a Philippine newspaper.
"When I saw the newspaper, this woman was begging for help," Samson said.
Tess Pantaleon was desperate for a pacemaker to replace the one she had because the battery was running out.
"She was only earning like $120 a month with five members of the family," Samson said.
Samson said that's when he recognized the need for pacemakers in underserved countries. He was able to secure one in the United States that was still usable and sent it to the Philippines' largest charged hospital in Manila.
Pantaleon recounted the events in a thank-you letter to World Medical Relief.
"I received a phone call from the Philippine General Hospital, who informed me that a pacemaker was available for me," Pantaleon said.
"They implanted the pacemaker the next day into this woman," Samson said.
At nearly the same time, Dr. Kim Eagle, director of the Cardiovascular Center at the University of Michigan, was faced with a related question.
"One of our cardiology fellows came to my office with a very unusual story," Eagle said. "He had put a pacemaker in a woman a few months before who subsequently died of heart failure."
The woman was being cremated, so the pacemaker needed to be removed. It was given to her husband by the funeral home and, realizing it was essentially new, he brought it to her doctor.
"(He said), 'I was you to take my wife's pacemaker and sterilize it and give it to someone in the world who can't afford one,'" Eagle said.
Since then, the University of Michigan has partnered with World Medical Relief to develop the My Heart, Your Heart pacemaker program, where previously used pacemakers are being tested, certified and reconditioned before being sent to help needy people in other countries.
"World Medical Relief, thank you very much for your help," Pantaleon said. "I hope you do not get tired of helping the poor like me. I should have been dead, but because of the pacemaker you sent, I am still alive."
While the concept is straightforward, setting up the world's first pacemaker reconditioning program has been an interesting challenge.
World Medical Relief is the perfect partner to develop Project My Heart Your Heart. Since its founding in Detroit in 1953, the organization has charitably distributed medical supplies around the world. Project My Heart Your Heart is a logical extension of that mission.
The process of reconditioning pacemakers begins at funeral homes. Currently, about 45 percent of all pacemakers are removed from the dead. Thirty-five percent must be removed because they are an explosion risk when a person is cremated. The additional 10 percent are removed at the discretion of the funeral home and the family. In the past, these pacemakers were either discarded as medical waste, sent back to the device manufacturers or sent to have the metals reclaimed. Project My Heart Your Heart has contacted funeral homes across America and has been able to reclaim over 25,000 for possible reuse. Roughly 20 percent of these reclaimed pacemakers are suitable for reuse.
The first thing that is tested is the remaining battery life.
“The ones that have four years or more -- those are prime devices for us to recycle.” Eagle said.
After that, the pacemakers go for an initial round of cleaning and sterilization. Then they're tested for function, a technically complex process.
According to Eagle, “For a while, it took us over an hour just to analyze whether a device responded properly.”
After working with the engineering department at the University of Michigan, the Project My Heart Your Heart team developed a box that simulates the electrical rhythms of a human heart. This has allowed the testing team to assess the function of a pacemaker in minutes.
Eagle said the goal is “to meet an industry level of standard for a new device, and if you’re that patient receiving a used device you would love that, to know that my device is having that same standard met.”
After some additional processing and an additional round of sterilization and packaging, the pacemakers are ready for export.
World Medical Relief and Project My Heart Your Heart has worked closely with the Food and Drug Administration to meet and exceed all applicable standards. According to Eagle, “The FDA had a very positive influence on our project … They’ve given us that export approval assuming we have letters from governments receiving the devices which we have.”
So far, pacemakers have been sent to such countries as Ghana, Sierra Leone, Pakistan, Nicaragua, Kenya and the Philippines. The patients receiving pacemakers will all be followed in a study to verify the ongoing track record of the devices.
“We're thinking big here, thinking the whole world and a million lives. This is a long-term goal. This is not a short-term fix. We want to do this correctly so that anybody looking at it says, "If you do it this way, it’s safe, it's effective and it can last,'” Eagle said.